Virtual Reality-supported Language Intervention for Preschool Children With DLD

NCT07438639 | Enrolling By Invitation

• 1 other identifier: VRRS_LOGO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to test the effectiveness of virtual reality-supported speech therapy in improving basic language skills in children aged 3 to 6 years diagnosed with Developmental Language Disorder (DLD). Participants are randomly assigned to either traditional speech therapy or virtual reality-supported therapy, with the same frequency and duration of intervention. Language outcomes are assessed before and after treatment using the Language development level test (TVL), a standardized assessment of Italian for preschoolers. The study adopts a randomized controlled design with individualized, goal-oriented therapy delivered by certified speech-language pathologists.

Conditions

Language Development Disorders

Outcome Measures

Primary Outcomes (1)

• Language Development Level Test (TVL)

  The Test of Verbalization and Language Development is a standardized tool designed to assess various aspects of language development, including verbal production, comprehension, sentence construction, phonological accuracy, and morphosyntactic abilities. The weighted score ranges from 0 to 10, with higher scores indicating better language development.

  Baseline and Month 3

Secondary Outcomes (1)

• Griffiths III Scales

  Baseline

Study Arms (2)

VR-Supported Speech Therapy

EXPERIMENTAL

Children receive two 60-minute sessions per week for six months using the Virtual Reality Rehabilitation System (VRRS).

Device: Virtual Reality Rehabilitation System (VRRS)

Traditional Speech Therapy

ACTIVE COMPARATOR

Children receive the same therapy schedule and goals through conventional speech-language sessions using printed materials, games, and verbal interaction.

Behavioral: Taditional Speech Therapy

Interventions

Virtual Reality Rehabilitation System (VRRS) DEVICE

The VRRS delivers personalized language therapy exercises via touchscreen interface. Activities target receptive language, repetition, naming, and spontaneous language production. All sessions are conducted by trained speech-language pathologists in accordance with standardized therapeutic protocols.

VR-Supported Speech Therapy

Taditional Speech Therapy BEHAVIORAL

Standard speech-language therapy delivered in-person by certified therapists, targeting the same language domains with paper-based and interactive materials.

Traditional Speech Therapy

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 3 and 6 years at enrollment
• Clinical diagnosis of Developmental Language Disorder (DLD) based on DSM-5 and standardized language assessments
• Developmental Quotient (DQ) \> 70 on the Griffiths III Scales
• Good general health without neurological or psychiatric comorbidities
• Informed consent signed by a parent or legal guardian

You may not qualify if:

• Age not between 3 and 6 years
• Lack of clinical diagnosis of Developmental Language Disorder (DLD)
• Developmental Quotient (DQ) \< 70 on the Griffiths Scale III
• Presence of neurological or psychiatric comorbidities
• Lack of signed informed consent from a parent or legal guardian

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

Francesca Cucinotta

Messina, Italy

Location

Related Publications (2)

• Cappadona I, Ielo A, La Fauci M, Tresoldi M, Settimo C, De Cola MC, Muratore R, De Domenico C, Di Cara M, Corallo F, Tripodi E, Impallomeni C, Quartarone A, Cucinotta F. Feasibility and Effectiveness of Speech Intervention Implemented with a Virtual Reality System in Children with Developmental Language Disorders: A Pilot Randomized Control Trial. Children (Basel). 2023 Aug 1;10(8):1336. doi: 10.3390/children10081336.

  PMID: 37628335 BACKGROUND

• van Vuuren S, Cherney LR. A Virtual Therapist for Speech and Language Therapy. Intell Virtual Agents. 2014 Jan 1;8637:438-448. doi: 10.1007/978-3-319-09767-1_55.

  PMID: 25938137 BACKGROUND

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 27, 2026
• Study Start: February 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

IT (1)